Drug updated on 9/4/2024
Dosage Form | Suspension (oral; 40 mg/mL) |
Drug Class | Corticosteroids |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
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Summary
- Agamree (Vamorolone) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Compared to Placebo: Vamorolone significantly increased TTSTAND velocity (MD = 0.04, 95% CI = 0.02-0.07, p = 0.002), TTRW velocity (MD = 0.24, 95% CI = 0.11-0.37, p = 0.0003), and TTCLIMB velocity (MD = 0.06, 95% CI = 0.05-0.06, p < 0.00001) in patients with Duchenne muscular dystrophy (DMD).
- Compared to Glucocorticoids: Vamorolone showed a significant increase in TTRW velocity (MD = -0.14, 95% CI = -0.26 to -0.01, p = 0.03) and height percentile for age (MD = 17.82, 95% CI = 3.89-31.75, p = 0.01) in patients with DMD.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Agamree (vamorolone) Prescribing Information. | 2023 | Santhera Pharmaceuticals (USA), Inc., Burlington MA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy of vamorolone in treatment of Duchene muscle dystrophy. A meta-analysis. | 2023 | Frontiers in Neurology |